Reata Pharmaceuticals announces FDA filing acceptance of SKYCLARYS NDA

Reata Pharmaceuticals announced that the FDA accepted for filing the Prior Approval Supplement to update the drug substance specification for SKYCLARYS or omaveloxolone. As per the US Code of Federal Regulation, the filing means FDA has made a threshold determination that the PAS is sufficiently complete to permit a substantive review. As previously communicated, the PAS is being reviewed under expedited Priority Review with a target action date of mid-August 2023.